CHICAGO (NewsNation) — Phenylephrine, an over-the-counter decongestant used to treat sinus congestion, doesn’t work, the U.S. Food and Drug Administration (FDA) determined.
After a long review of the efficiency of the drug, the FDA declared the drug was not effective as a nasal decongestant at the suggested dosage. The results were posted in a lengthy briefing last week, meant to inform the Nonprescription Drug Advisory Committee of the review’s findings ahead of a meeting to be held on Monday and Tuesday.
“We have now come to the initial conclusion that orally administered PE is not effective as a nasal decongestant at the monographed dosage (10 mg of PE hydrochloride every 4 hours) as well as at doses up to 40 mg (dosed every 4 hours),” the FDA said.
The drug can be found in common household medicines like Sudafed PE, Nyquil, Mucinex, Vicks Sinex and Benadryl Allergy Plus Congestion.
Now, the committee must vote on phenylephrine’s efficiency. If determined ineffective, the FDA would have to mark it unsafe for over-the-counter sales. Phenylephrine was originally approved by the FDA in the 1970s and has been sold in several forms, NBC News reported.
However, while the FDA has predetermined the drug was ineffective, it did not request phenylephrine be pulled from stores. Instead, the FDA requested more data on how the drug worked at higher doses, the NBC News report said.
Discovering the drug doesn’t in fact work and pulling it from shelves would be devastating to the public, as phenylephrine is the only available medication for those seeking an affordable and timely solution, especially after the FDA moved pseudoephedrine “behind-the-counter” almost 20 years ago, MedPage Today reported.
If voted ineffective by the committee, phenylephrine will be pulled from the public and those seeking a remedy will have to seek out alternative treatments, the FDA said.